SoCRA CERTIFICATION EXAM AND PRACTICE EXAM NEWEST
VERSION ACTUAL QUESTION AND CORRECT DETAILED
VERIFIED ANSWERS FROM VERIFIED SOURCES RATED A
GRADE.
How many members are required to be on an IRB? - ANSWER-5
members, with varying backgrounds to promote complete and
adequate review of researchj
How does one consent if they can't read? - ANSWER-Oral
explanation with a signature from an IMPArTIAL WITNESS
How does a non-therapeutic trial differ from a therapeutic trial? -
ANSWER-There is no anticipated benefit for the subject. This
makes it less appealing to participate. It should be an
autonomous person's decision to participate in a non-therapeutic
trial. Whenever possible, LARs should not enroll their dependents
in such trials because there is no expected benefit. (THERE ARE
EXPECTATIONS)
Changes to SOURCE DATA must be.... - ANSWER-TRACEABLE!!!
(electronic audits or handwritten single strikethorugh with date
and initials!)
,Should SAEs be reported to the sponsor? - ANSWER-Yes.
Immediately. Can follow up later with a detailed report
IF a trial is ended prematurely, are you supposed to tell prior
participants? -
ANSWER-Yes
allocation of responsibility - ANSWER-sponsor should define,
establish, and allocate all trial related functions
Centralized Monitoring - ANSWER-You don't physically travel to
sites. You may randomly sample data to check for errors, etc.
Monitor report - ANSWER-after every site visit, the monitor should
submit a report tot he sponsor. reco's, criticisms, etc.
How often should monitors visit? - ANSWER-Decided by the
sponsor - can be relative to the risk involved in the study.
Does the ICH GCP spell out the sections of a protocol? -
ANSWER-Yes! you can guess
Does the ICH GCP spell out recommended format of an
investigator's brochure? - ANSWER-yep
,The ICH GCP spells out all essential trial documents, WHEN they
should be employed, and WHO keeps them (sponsor vs.
investigator) - ANSWER-okay!
Who needs to keep documentation of IRB approval? - ANSWER-
Both - sponsor & investigator
How does the definition of an ADR change when a drug goes from
pre-approval to post-approval? - ANSWER-Pre-approval, ANY
dosage that causes bad reaction is an ADR. AFTER approval, an
ADR is only a bad reaction at an approved dose (i.e. an overdose..
or a microdose wouldn't be appropriate)_
If a IB lists "kidney problems" as an adverse side effect, and
youre patient develops a specific type of nephritis, would that be
considered Expected? - ANSWER-No. If it brings new light, new
SPECIFICS to the table on side effects... it is still considered
unexpected and reporting that problem would be BENEFICIAL!!!
What type of ADR needs to be reported in an EXPEDITED
manner? (2 criteria) -
ANSWER-SERIOUS AND
UNEXPECTED
, Are there situations, other than a serious and unexpected ADR,
which require expedited reporting? - ANSWER-Yes. For example,
if an expected reaction is happening at a higher-than-expected
rate. A new animal study finding. Lack of efficacy in patients with
life threatening disease.
Describe the timeframe for expedited reporting FATAL or LIFE-
THREATENING and UNEXPECTED ADRs - ANSWER-ASAP, but
no later than 7 calendar days by first knowledge of the sponsor.
A COMPLETE report will be required within 8 additional calendar
days
Describe the timeframe for expedited reporting- SERIOUS,
UNEXPECTED ADRs (not life-threatening) - ANSWER-ASAP, but
no later than 15 calendar days after first knowledge by the
sponsor
What form is used to report serious, unexpected ADRs? -
ANSWER-CIOMIS-I is widely used, but it doesn't matter as long as
it contains specified information
Should you break a blind for a serious, unexpected ADR? -
ANSWER-Yes, if a case is serious enough to warrant EXPEDITED
REPORTING. Only for that one patient.
VERSION ACTUAL QUESTION AND CORRECT DETAILED
VERIFIED ANSWERS FROM VERIFIED SOURCES RATED A
GRADE.
How many members are required to be on an IRB? - ANSWER-5
members, with varying backgrounds to promote complete and
adequate review of researchj
How does one consent if they can't read? - ANSWER-Oral
explanation with a signature from an IMPArTIAL WITNESS
How does a non-therapeutic trial differ from a therapeutic trial? -
ANSWER-There is no anticipated benefit for the subject. This
makes it less appealing to participate. It should be an
autonomous person's decision to participate in a non-therapeutic
trial. Whenever possible, LARs should not enroll their dependents
in such trials because there is no expected benefit. (THERE ARE
EXPECTATIONS)
Changes to SOURCE DATA must be.... - ANSWER-TRACEABLE!!!
(electronic audits or handwritten single strikethorugh with date
and initials!)
,Should SAEs be reported to the sponsor? - ANSWER-Yes.
Immediately. Can follow up later with a detailed report
IF a trial is ended prematurely, are you supposed to tell prior
participants? -
ANSWER-Yes
allocation of responsibility - ANSWER-sponsor should define,
establish, and allocate all trial related functions
Centralized Monitoring - ANSWER-You don't physically travel to
sites. You may randomly sample data to check for errors, etc.
Monitor report - ANSWER-after every site visit, the monitor should
submit a report tot he sponsor. reco's, criticisms, etc.
How often should monitors visit? - ANSWER-Decided by the
sponsor - can be relative to the risk involved in the study.
Does the ICH GCP spell out the sections of a protocol? -
ANSWER-Yes! you can guess
Does the ICH GCP spell out recommended format of an
investigator's brochure? - ANSWER-yep
,The ICH GCP spells out all essential trial documents, WHEN they
should be employed, and WHO keeps them (sponsor vs.
investigator) - ANSWER-okay!
Who needs to keep documentation of IRB approval? - ANSWER-
Both - sponsor & investigator
How does the definition of an ADR change when a drug goes from
pre-approval to post-approval? - ANSWER-Pre-approval, ANY
dosage that causes bad reaction is an ADR. AFTER approval, an
ADR is only a bad reaction at an approved dose (i.e. an overdose..
or a microdose wouldn't be appropriate)_
If a IB lists "kidney problems" as an adverse side effect, and
youre patient develops a specific type of nephritis, would that be
considered Expected? - ANSWER-No. If it brings new light, new
SPECIFICS to the table on side effects... it is still considered
unexpected and reporting that problem would be BENEFICIAL!!!
What type of ADR needs to be reported in an EXPEDITED
manner? (2 criteria) -
ANSWER-SERIOUS AND
UNEXPECTED
, Are there situations, other than a serious and unexpected ADR,
which require expedited reporting? - ANSWER-Yes. For example,
if an expected reaction is happening at a higher-than-expected
rate. A new animal study finding. Lack of efficacy in patients with
life threatening disease.
Describe the timeframe for expedited reporting FATAL or LIFE-
THREATENING and UNEXPECTED ADRs - ANSWER-ASAP, but
no later than 7 calendar days by first knowledge of the sponsor.
A COMPLETE report will be required within 8 additional calendar
days
Describe the timeframe for expedited reporting- SERIOUS,
UNEXPECTED ADRs (not life-threatening) - ANSWER-ASAP, but
no later than 15 calendar days after first knowledge by the
sponsor
What form is used to report serious, unexpected ADRs? -
ANSWER-CIOMIS-I is widely used, but it doesn't matter as long as
it contains specified information
Should you break a blind for a serious, unexpected ADR? -
ANSWER-Yes, if a case is serious enough to warrant EXPEDITED
REPORTING. Only for that one patient.
